Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study prematurely discontinued in May 2008 prior to reaching planned enrollment target; Last subject last visit November 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Familial Adenomatous Polyposis (FAP) identified subjects=celecoxib-treated and matched control subjects eligible for inclusion in study identified from 4 registry sites; FAP analyzed=celecoxib-treated and matched control subjects eligible for matching and analysis in study. 1 subject excluded from analysis; took celecoxib without a prescription.

Reporting Groups

	Description
Matched Control	Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
All Celecoxib Treated	All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.

Participant Flow for 2 periods

Period 1:   FAP Identified Subjects

	Matched Control	All Celecoxib Treated
STARTED	13	55
COMPLETED	13	54
NOT COMPLETED	0	1
Protocol Violation	0	1

Period 2:   FAP Analyzed Subjects

	Matched Control	All Celecoxib Treated
STARTED	13	54
COMPLETED	13	51
NOT COMPLETED	0	3
Lost to Follow-up	0	2
Other study participation	0	1

Reporting Groups

	Description
Matched Celecoxib Treated	Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Matched Control	Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
Not Matched Celecoxib Treated	Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.

Baseline Measures

	Matched Celecoxib Treated	Matched Control	Not Matched Celecoxib Treated	Total
Number of Participants   [units: participants]	13	13	41	67
Age, Customized [1] [units: participants]
<25 years	4	5	18	27
25 to 34 years	5	4	5	14
35 to 44 years	3	2	8	13
45 to 54 years	1	1	3	5
55 to 64 years	0	0	1	1
>64 years	0	0	0	0
Age not available (no surgery)	0	1	6	7
Gender   [units: participants]
Female	2	6	21	29
Male	11	7	20	38

1.  Primary:

Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA   [ Time Frame: Up to 8 years prior to baseline ]

2.  Primary:

Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA   [ Time Frame: Baseline, Up to 60 months post-baseline ]

3.  Primary:

Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA   [ Time Frame: Up to 15 years prior to baseline ]

4.  Primary:

Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA   [ Time Frame: Baseline, Up to 60 months post-baseline ]

5.  Secondary:

Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas (Duodenal Adenomatous Polyps)   [ Time Frame: Up to 15 years prior to baseline ]

6.  Secondary:

Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas   [ Time Frame: Baseline, Up to 60 months post-baseline ]

7.  Secondary:

Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event   [ Time Frame: Up to 15 years prior to baseline ]

8.  Secondary:

Time From Start of Study Follow-up to Time of First FAP-related Adverse Event   [ Time Frame: Baseline, Up to 60 months post-baseline ]

9.  Secondary:

Time From Post IRA to Time of Conversion From IRA to IPAA   [ Time Frame: Up to 15 years prior to baseline ]

10.  Secondary:

Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA   [ Time Frame: Baseline, Up to 60 months post-baseline ]

11.  Secondary:

Duodenal Adenoma Burden as Measured by Spigelman Stage   [ Time Frame: Baseline, 6 to 14 months post-baseline, End of study (EOS) ]

12.  Secondary:

Rectal or Pouch Adenoma Burden Based on Polyp Counts   [ Time Frame: Baseline, 6 to 14 months post-baseline, EOS ]

13.  Post-Hoc:

Duodenal Adenoma Burden as Measured by Polyp Counts   [ Time Frame: Baseline, 6 to 14 months post-baseline, End of study (EOS) ]